FDA 483 - Acino Products, LLC - May 21, 2025

An FDA inspection of Acino Products, LLC in Hamilton, NJ, an OTC finished drug product distributor, revealed significant deficiencies. The firm failed to maintain adequate environmental controls for drug product storage in a residential garage, lacked scientific data to support expiration dates, and did not have a written quality control unit procedure for handling complaints. These issues include repeat observations from previous inspections.